Varenicline for the treatment of cocaine dependence: Phase II

描述（由申请人提供）：伐尼克兰治疗可卡因依赖：II期临床试验。可卡因依赖仍然是一个主要的公共卫生问题，即使在二十多年的稳步尝试，以开发有效的行为和药理干预治疗可卡因依赖。 由于可卡因使用直接造成的健康成本（例如，冠状动脉和血管问题），以及那些更间接的问题（例如，艾滋病、丙型肝炎病毒的传播来自性交易毒品），当务之急是继续努力开发有效的治疗方法。 为此，这是一项拟定的伐尼克兰治疗可卡因依赖的双盲安慰剂对照临床试验（n = 200），该试验利用应急管理来促进治疗出勤率。 在最近完成的使用相同设计的试点试验（n = 37）中，我们发现随机分配至伐尼克兰的受试者显示可卡因使用的更大降低以及他们发现可卡因的价值或强化程度的降低（Plebani等人，正在审查中的订正）。 在这项研究中，我们使用了一个可变的强化时间表，以促进高出勤率。 这种强化导致了出席率的大幅提高，并导致数据缺失比通常困扰此类试验的数据少得多。 由于这些有希望的结果，我们现在寻求在更大的样本中复制该研究，以便能够更全面地确定伐尼克兰作为可卡因依赖治疗的疗效。 公共卫生相关性：可卡因依赖是一个主要的公共卫生问题，有效的治疗方法很少，复发率高，并且与负面健康后果有很强的关联。因此，需要研究潜在的可卡因依赖药物。这种研究应利用行为干预，以最大限度地提高治疗出勤率和保留率，以更好地确定药物疗效，从而减少可卡因依赖对医疗保健系统和社会的负担。

DESCRIPTION (provided by applicant): Varenicline for the treatment of cocaine dependence: A phase II clinical trial. Cocaine dependence remains a major public health problem, even after over two decades of steady attempts to develop effective behavioral and pharmacological interventions for treating cocaine dependence. Due to the health costs that come directly from cocaine use (e.g., coronary and vascular problems), and those that are more indirect (e.g., spread of AIDS, HCV from exchanging sex for drugs), it is imperative that efforts to develop efficacious treatments continue. To that end, this is a proposed double-blind placebo-controlled clinical trial (n = 200) of varenicline for the treatment of cocaine dependence that utilizes contingency management to promote treatment attendance. In a recently completed pilot trial (n = 37) using the same design, we found that subjects randomized to varenicline showed greater decreases in cocaine use as well as reductions in how valuable or reinforcing they found cocaine (Plebani et al., revision under review). In that study, we used a variable schedule of reinforcement to promote high rates of attendance. That reinforcement led to dramatic increases in attendance rates, and led to far less missing data than usually plagues such trials. Due to these promising results, we now seek to replicate that study in a larger sample in order to have the power to more fully determine the efficacy of varenicline as a treatment for cocaine dependence. PUBLIC HEALTH RELEVANCE: Cocaine dependence is a major public health problem, with few effective treatments, high relapse rates, and a strong association with negative health consequences. As such, research examining potential cocaine dependence medications is needed. Such research should utilize behavioral intervention to maximize treatment attendance and retention in order to better determine medication efficacy, and thus decrease the burden that cocaine dependence places on the healthcare system and on society.